The legal battle between the Ministry of Food and Drug Safety (MFDS) and Medytox over the "indirect export" of the latter’s botulinum toxin (BTX) products has entered the second round.

Indirect export refers to selling BTX products to domestic distributors without getting lot release approval from the government. 

Medytox said in a public filingThursday that the head of the Daejeon Food and Drug Safety Office, a defendant in two lawsuits – one for revoking an order to stop manufacturing and sales and the other for revoking a product approval-- has appealed the first trial judgment in each case.

That means the MFDS has effectively challenged the court’s judgment on indirect export.

According to Medytox, the purpose of the Daejeon Food and Drug Safety Office’s appeal is to cancel the first trial judgment, dismiss the plaintiff's (Medytox's) claim, and bear the plaintiff's costs for the first and second trials. The jurisdictional court is the Daejeon High Court.

On July 6, the Administrative Division 3 of the Daejeon District Court ruled in favor of Medytox, citing the plaintiff's claims in a lawsuit against the Daejeon Food and Drug Safety Office for revoking the order to stop manufacturing and sales and revoking the product approval.

After the first trial, the MFDS said it would review the ruling and decide whether to appeal. The ministry seems to have judged it could overturn the district court’s ruling in the appeal trial since it had to win the final approval (i.e., an instruction upon request) from the Ministry of Justice even after it decided to appeal the cases.

As a result of the appeal, Medytox has come to share the risk of prolonged administrative proceedings related to indirect exports. However, the market remained cautious after the announcement. At Thursday noon, Medytox's stock price was up 1.89 percent, 4,000 won, from the previous day's closing price of 215,500 won ($168.7) per share.

The appeals decision will likely put the domestic botulinum toxin industry executives’ nerves on edge, market watchers said.

Many BTX makers, including Hugel, PharmaResearchBio, Jetema, BNC Korea, BMI Korea, and Huons Biopharma, have received administrative penalties from the ministry for indirect exports.